Acute Norvolecmic Hemodilution (ANH) is one of the effective methods to reduce the need for allogeneic blood transfusion, and its positive effects have been proven in various studies.
Design
Patients are divided into two groups by simple random sampling based on the case number and table of random numbers. A double-blinded control clinical trial is performed on 172 patients.
Settings and conduct
All the procedures and data recording are done in the operation room. The study is designed to be double-blinded, the analyzer and the patients are blind. The professor performs all procedures, and the anesthesiologist's assistant records the data. The patient is unaware of being in the study group.
Participants/Inclusion and exclusion criteria
CABG candidates with Hemoglobin levels above 14 g/dL and Left Ventricular Ejection Fraction above 35% will be interviewed to participate in our study.
Intervention groups
1. in the intervention group, after explaining the steps of the study, and obtaining the patient's consent to participate in the study, after induction of anesthesia, CV-line, and arterial line insertion, a unit of blood is taken from the patient through an arterial catheter in the standard bag of the blood transfusion organization. In some patients with Hb levels above 16, two units of blood are going to be taken. Each 1 cc of blood will be replaced with 3 ccs of intravascular normal saline. 2. In control group after obtaining patient's consent, induction of anesthesia, CV-line and Arterial line insertion, without drawing any blood, we will proceed to surgery.
Main outcome variables
The need for blood transfusion
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180603039966N2
Registration date:2022-11-12, 1401/08/21
Registration timing:prospective
Last update:2022-11-12, 1401/08/21
Update count:0
Registration date
2022-11-12, 1401/08/21
Registrant information
Name
Sina Hasannasab
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 17 3235 2508
Email address
sina.hasannasab@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-11-21, 1401/08/30
Expected recruitment end date
2023-02-19, 1401/11/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effect of Acute Normovolemic Hemodilution(ANH) on hemodynamics and blood transfusion rate in patients undergoing on-pump CABG
Public title
ANH effect on hemodynamic and blood transfusion rate in CABG patients
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
CABG candidates with hemoglubin level above 14 g/dL
CABG candidates with left Ventricular Ejection Fraction above 35%
Exclusion criteria:
Patients refusal to participate
History of cerebrovascular accident(ischemic or hemorrhagic)
History of carotid stenosis
History of ischemia or active bleeding(GI bleeding, mesenteric ischemia, claudication)
History of renal failure
History of liver failure
Age
No age limit
Gender
Both
Phase
3
Groups that have been masked
Participant
Data analyser
Sample size
Target sample size:
172
More than 1 sample in each individual
Number of samples in each individual:
86
Patients who are admitted to Amir-al-Momenin hospital in Kordkoy and Baqiyatallah hospital in Tehran for elective CABG are evaluated to participate in the study.
Randomization (investigator's opinion)
Randomized
Randomization description
Based on the table of random numbers, a column is randomly selected and choose the right side column, If the last digit of the number selected is the same as the patient's last digit case number, the patient will be in the intervention group, and otherwise in the control group.
Blinding (investigator's opinion)
Double blinded
Blinding description
The professor does all the procedures and the data is recorded by the anesthesia technician. The data analyzer does the analysis based on groups A and B. The patient is anesthetized during the entire surgery and procedure and unaware of the study groups.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Glestan Medical University Ethics Committee
Street address
shastkola road
City
Gorgan
Province
Golestan
Postal code
4916694667
Approval date
2021-10-31, 1400/08/09
Ethics committee reference number
IR.GOUMS.REC.1401.002
Health conditions studied
1
Description of health condition studied
Patients undergoing On-Pump CABG
ICD-10 code
I25.70
ICD-10 code description
Atherosclerosis of coronary artery bypass graft(s), unspecified, with angina pectoris
Primary outcomes
1
Description
Need for blood transfusion
Timepoint
Will be recorded during surgery and until the discharge from the ICU.
Method of measurement
Number of packed cell transfused
Secondary outcomes
1
Description
Mean Arterial Pressire(MAP)
Timepoint
Will be recorded during surgery and also at 0, 6, 12, 24 hours after the surgery, And if necessary, will be assessed PRN
Method of measurement
Transducer via Arterial line catheter
2
Description
Systolic Blood Pressure(SBP)
Timepoint
Will be recorded during surgery and also at 0, 6, 12, 24 hours after the surgery, And if necessary, will be assessed PRN
Method of measurement
Transducer via Arterial line catheter
3
Description
Diastolic Blood Pressure(DBP)
Timepoint
Will be recorded during surgery and also at 0, 6, 12, 24 hours after the surgery, And if necessary, will be assessed PRN
Method of measurement
Transducer via Arterial line catheter
4
Description
Urine Output(U/O)
Timepoint
Will be recorded during surgery and also at 0, 6, 12, 24 hours after the surgery, And if necessary, will be assessed PRN
Method of measurement
Urinary drainage Bag
5
Description
Central Vein Pressure
Timepoint
Will be recorded during surgery and also at 0, 6, 12, 24 hours after the surgery, And if necessary, will be assessed PRN
Method of measurement
CVP Manometer set
6
Description
Arterial Blood PH
Timepoint
Will be recorded during surgery and also at 0, 6, 12, 24 hours after the surgery, And if necessary, will be assessed PRN
Method of measurement
ABG Analyzer
7
Description
Partial pressure of oxygen(Pao2)
Timepoint
Will be recorded during surgery and also at 0, 6, 12, 24 hours after the surgery, And if necessary, will be assessed PRN
Method of measurement
ABG Analyzer
8
Description
Partial pressure of carbon dioxide (PaCO2)
Timepoint
Will be recorded during surgery and also at 0, 6, 12, 24 hours after the surgery, And if necessary, will be assessed PRN
Method of measurement
ABG Analyzer
Intervention groups
1
Description
Intervention group: Patients who are admitted to Amir-al-Momenin hospital in Kordkoy and Baqiyatallah hospital in Tehran for elective CABG who undergoes Acute Normovolemic Hemodilution. Every 1cc of blood taken from the patient's arterial catheter is compensated with 3cc of intravenous normal saline, the parameters are measured, and the stored blood is injected into the patient at the end of the surgery.
Category
Treatment - Other
2
Description
Control group: Intervention group: Patients who are admitted to Amir-al-Momenin hospital in Kordkoy and Baqiyatallah hospital in Tehran for elective CABG who does not undergo Acute Normovolemic Hemodilution. In these patients, an arterial catheter is routinely inserted and hemodynamic parameters are also recorded.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Amir-al-Momenin hospital
Full name of responsible person
Dr. Amirali Jabbari
Street address
Sardar Jangal
City
Kordkoy
Province
Golestan
Postal code
4881899441
Phone
+98 17 3432 5766
Email
h.kordkoy@goums.ac.ir
Web page address
https://kordkuyheartcenter.goums.ac.ir//
2
Recruitment center
Name of recruitment center
Baqiyatallah hospital
Full name of responsible person
Seyyed Mohammad Saeed Ghiasi
Street address
Vanak Square, Mulla Sadra Street, after Sheikh Bahayi
City
Tehran
Province
Tehran
Postal code
141556437
Phone
+98 21 81261
Email
baqhospital@mail.bmsu.ac.ir
Web page address
https://baq.bmsu.ac.ir/portal/home/
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Gorgan University of Medical Sciences
Full name of responsible person
Amirali Jabbari
Street address
Shast-kola Road, Hirkan blvd
City
Gorgan
Province
Golestan
Postal code
4934174515
Phone
+98 17 3245 2651
Email
Gsm@goums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Gorgan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Gorgan University of Medical Sciences
Full name of responsible person
Amirali Jabbari
Position
Assistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
Anesthesiology
Street address
Shast-kola Road, Hirkan blvd
City
Gorgan
Province
Golestan
Postal code
4934174515
Phone
+98 17 3245 2651
Email
dr.a.jabbari@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Gorgan University of Medical Sciences
Full name of responsible person
Amirali Jabbari
Position
Assistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
Anesthesiology
Street address
Shast-kola Road, Hirkan blvd
City
Gorgan
Province
Golestan
Postal code
4934174515
Phone
+98 17 3245 2651
Email
dr.a.jabbari@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Gorgan University of Medical Sciences
Full name of responsible person
Sina Hassannasab
Position
Consultant
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Shast-kola Road, Hirkan blvd
City
Gorgan
Province
Golestan
Postal code
4934174515
Phone
+98 17 3245 2651
Email
Drsina.hsn@goums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available